TSCA Section 4 Test Rules, Consent Orders, Enforceable Consent Agreements, Voluntary Testing Agreements, Voluntary Data Submissions, and Exemptions from Testing Requirements (Reinstatement)

Forms and Documents

Document Name	Status
1139ss11_Attach6-ConsultationsEmail.pdf Supplementary Document	2018-02-08
1139ss11_Attach5-EPAResponse.pdf Supplementary Document	2018-02-08
1139ss11_Attach4-PublicComment.pdf Supplementary Document	2018-02-08
1139ss11_Attach3-EconomicTables.docx Supplementary Document	2018-02-08
1139ss11_Attach2-regs.docx Supplementary Document	2018-02-08
1139ss11_Attach1-statute.docx Supplementary Document	2018-02-08
1139ss11_rev.docx Supporting Statement A	2018-10-16

IC Document Collections

IC ID	Document Title	Status
24877	Testing Agreements	Modified
229554	CDX Registration	New
202057	Laboratory Costs	Modified
202056	Testing Exemption Applications	Modified
202055	Voluntary Testing Submission	Modified
202054	Testing Rules	Modified

ICR Details

OMB Control No: 2070-0033	ICR Reference No: 201712-2070-004
Status: Historical Active	Previous ICR Reference No: 201204-2070-002
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 1139.11
Title: TSCA Section 4 Test Rules, Consent Orders, Enforceable Consent Agreements, Voluntary Testing Agreements, Voluntary Data Submissions, and Exemptions from Testing Requirements (Reinstatement)
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 10/17/2018
	Date Received in OIRA: 02/08/2018
Terms of Clearance: Upon resubmision, the agency is reminded to provide copies of the mode of collection in addition to the instructions. This collection is limited to collection activities that the agency had authority for prior to the Lautenberg Act.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2021	36 Months From Approved
Responses	36	0	0
Time Burden (Hours)	3,127	0	0
Cost Burden (Dollars)	9,010,065	0	0

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Abstract: Section 4 of the Toxic Substances Control Act (TSCA) is designed to assure that chemicals that may pose serious risks to human health or the environment undergo testing by manufacturers or processors, and that the results of such testing are made available to EPA. EPA uses the information collected under the authority of TSCA section 4 to assess risks associated with the manufacture, processing, distribution, use or disposal of a chemical, and to support any necessary regulatory action with respect to that chemical. EPA must assure that appropriate tests are performed on a chemical if it decides: (1) that a chemical being considered under TSCA section 4(a) may pose an "unreasonable risk" or is produced in "substantial" quantities that may result in substantial or significant human exposure or substantial environmental release of the chemical; (2) that additional data are needed to determine or predict the impacts of the chemical's manufacture, processing, distribution, use or disposal; and (3) that testing is needed to develop such data. Rules and consent orders under TSCA section 4 require that one manufacturer or processor of a subject chemical perform the specified testing and report the results of that testing to EPA. TSCA section 4 also allows a manufacturer or processor of a subject chemical to apply for an exemption from the testing requirement if that testing will be or has been performed by another party. This information collection applies to reporting and recordkeeping activities associated with the information that EPA requires industry to provide in response to TSCA section 4 test rules, consent orders, test rule exemptions and other data submissions.

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Authorizing Statute(s): US Code: 15 USC 2603 et seq. Name of Law: Toxic Substances Control Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 13790	03/15/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 58599	12/13/2017
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Testing Agreements
Testing Rules
Voluntary Testing Submission
Testing Exemption Applications
Laboratory Costs
CDX Registration

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	36	0	0	8	-2,389	2,417
Annual Time Burden (Hours)	3,127	0	0	4	-626,770	629,893
Annual Cost Burden (Dollars)	9,010,065	0	0	0	-618,376	9,628,441

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: The adjustment decrease reflects EPAs corrections to the previous renewal of this collection, plus reduced levels of activity in test rules, methodological corrections and updates, and requirements for electronic reporting of information. The program change increase is related to the activities new, first-time respondents must undertake to register with EPA's Central Data Exchange (CDX) so as to be able to make electronic submissions of information.

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Annual Cost to Federal Government: $38,553

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 02/08/2018

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